Dockets Management Branch
Food & Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Dear Sir/Madam,
Millions of consumers contacted Congress in 1993/94 urging support for the regulatory framework, the Dietary Supplement Health & Education Act (DSHEA) in order to provide important health information and products to consumers and to ensure the safety of these products. The unanimous passage of the law reflected the overwhelming number of constituents demanding access to nutritional supplements.
DSHEA gives considerable powers to the federal government to assure the safety of supplements and the accuracy of health claims. Specifically, DSHEA provides FDA with the authority to:
· Stop any company from selling a dietary supplement that is adulterated or misbranded.
· Stop the sale of a dietary supplement that makes false or unsubstantiated claims.
· Take action against any dietary supplement that poses a significant or unreasonable risk of illness or injury.
· Stop any company making a claim that a product cures or treats a disease.
· Require dietary supplements companies to meet strict manufacturing standards, including potency, cleanliness and accurate labeling.
Former FDA commissioner Dr. Jane Henney, in fact, testified before Congress that DSHEA provides FDA with the necessary legal authority to protect the public health.
The request in this request for comments to consider additional legislative authority is troubling. The FDA has enough legislative authority to regulate the supplement market, including products containing ephedra, but examining its history shows how slow they have been to implement the law. The FDA has just recently taken steps to use the authority they were granted 9 years ago. Guidelines for Good Manufacturing Practices, mandated by DSHEA in 1994, were just released for comment March 7th, 2003. Steps were only recently taken to address unsubstantiated claims.
I urge the FDA to focus on fully implementing DSHEA and to adhere to the original intent of the law as mandated by hundreds of thousands of consumer voices.